FDA 510(k) Application Details - K140368

Device Classification Name	Prism, Gonioscopic   More FDA Info for this Device
510(K) Number	K140368
Device Name	Prism, Gonioscopic
Applicant	SENSOR MEDICAL TECHNOLOGY, LLC 5 TIMBER LANE NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL Other 510(k) Applications for this Contact
Regulation Number	886.1660   More FDA Info for this Regulation Number
Classification Product Code	HKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2014
Decision Date	04/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review